Sr. Engineering Project Manager
9 days ago
Andover
Job DescriptionWhat Makes This Role Compelling • Lead complex, cross-functional medical device programs that directly influence clinical outcomes and product success., • Play a key role in taking innovative hardware, software, and disposable technologies from concept to commercialization., • Lead end-to-end execution of medical device development programs., • Build and manage program plans including scope, schedules, budgets, and risk mitigation., • Oversee design control activities and ensure documentation supports regulatory readiness., • Contribute to DHF, technical documentation, and submission-support materials., • Facilitate phase-gate reviews and ensure compliance with quality and regulatory requirements., • Track program metrics, identify risks, and drive timely issue resolution., • Partner with R&D, Quality, Operations, and external teams to support feasibility, prototyping, and transfer to manufacturing., • Support continuous improvement in program processes and engineering execution.Requirements, • Bachelor’s degree in Mechanical, Biomedical, or related engineering discipline., • 7+ years of engineering or project management experience within medical devices., • Permanent authorization to work in the United States., • Experience leading development of complex systems (hardware, disposables, and/or software)., • Strong understanding of design controls and regulated development processes., • Demonstrated ability to manage cross-functional teams and drive accountability., • Excellent communication, organization, and problem-solving abilities.